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Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach

Primary Purpose

Hip, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Direct Anterior Approach (DAA)
Anterolateral approach
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hip focused on measuring total, hip, arthroplasty, surgical, approach

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient's consent for anticipation in the study
  • BMI less than 35
  • ability to walk the distance of 10m and stand up from the chair
  • arthroplasty in one hip

Exclusion Criteria:

  • patient's lack of consent for anticipation in the study
  • neurological diseases
  • balance disorders
  • reoperations in the area of endoprosthesis
  • muscles diseases
  • rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis)
  • dizziness, vasovagal syncope

Sites / Locations

  • Department of Orthopedics and Rehabilitation, Medical University of Warsaw
  • Orthopaedics and Rehabilitation Department, Medical University of Warsaw

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Direct Anterior Approach (DAA)

Anterolateral approach

Posterolateral approach

Arm Description

Direct Anterior Approach surgery to replace the hip.

Anterolateral Approach surgery to replace the hip.

Posterolateral Approach surgery to replace the hip.

Outcomes

Primary Outcome Measures

Change in biomechanical gait parameters
Done by a biomechanics lab for patients to test their hip movements
Gluteus medius muscle fatigue
Surface Electromyographic analysis performed for testing gluteus medius activity
Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)
This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score. This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
This measures health status as it relates to the hip. There are 3 subscales, pain which score ranges from 0-20, stiffness range from 0-8, physical function ranging from 0-68. The total score is just added up from the subscales.
Change in Oxford scale
The Oxford scale is a physiotherapist objective-rated scale to asses muscle strength against the resistance. It is graded from 0 (flicker of movement) to 5 (Through full range actively against strong resistance)
Change in SF-36 scale
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Change in Visual Analog Scale (VAS) scale
To measure pain. This is a line with left most end representing no pain with the rightmost representing extreme pain. The participant puts a line where they feel that day and it is measured with a ruler to determine score out of 100. The line is 100mm long.
Change in biomechanical gait balance
Done by a biomechanics lab for patients to test their gait balance
Change in biomechanical coordination
Done by a biomechanics lab for patients to test their hip movements coordination

Secondary Outcome Measures

Radiological analysis of implants positioning
To measure angles associated with proper implants positioning

Full Information

First Posted
September 15, 2018
Last Updated
October 5, 2021
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT03850665
Brief Title
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
Official Title
Comparison of Early Objective and Subjective Outcome in Patients After Hip Arthroplasty, Operated From Direct Anterior, Posterolateraland Anterolateral Approach: Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 27, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study will be to compare functional outcomes of the two surgical hip approaches in total hip arthroplasty: anterior, posterolateral and anterolateral. Surgical approach may have influence on patients functional outcome.
Detailed Description
Patients with primary hip osteoarthritis will be included in a randomized controlled trial and assigned to total hip arthroplasty using one the of hip approaches: anterior or anterolateral. Subjects will be assessed preoperative and 3 and 12 moths postoperative. Biomechanical gait parameters will be collected using tree-dimensional motion analysis system "BTS SMART". Evaluation of the function of the middle gluteal muscle with superficial EMG (sEMG) percutaneous surface electromyography. Fatigue assessment (mean frequency and amplitude) of the gluteus medius muscle during isometric muscle contraction. Balance and coordination as well as fall risk will be assessed with use of dynamometric Biodex Balance platform. The study will determine the values of individual indicators: general stability index (OWS), anterior-posterior stability index (APW), the median lateral stability index (MLW) and the fall risk index (RU). Subjective assessment will be conducted with use of Visual Analogue Scale, WOMAC Index, Oxford Hip Score, The Short Form-36 (SF-36) and Harris Hip Score

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip, Osteoarthritis
Keywords
total, hip, arthroplasty, surgical, approach

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct Anterior Approach (DAA)
Arm Type
Active Comparator
Arm Description
Direct Anterior Approach surgery to replace the hip.
Arm Title
Anterolateral approach
Arm Type
Active Comparator
Arm Description
Anterolateral Approach surgery to replace the hip.
Arm Title
Posterolateral approach
Arm Type
Active Comparator
Arm Description
Posterolateral Approach surgery to replace the hip.
Intervention Type
Procedure
Intervention Name(s)
Direct Anterior Approach (DAA)
Intervention Description
Direct Anterior Approach surgery to replace the hip.
Intervention Type
Procedure
Intervention Name(s)
Anterolateral approach
Intervention Description
Anterolateral approach surgery to replace the hip.
Primary Outcome Measure Information:
Title
Change in biomechanical gait parameters
Description
Done by a biomechanics lab for patients to test their hip movements
Time Frame
from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Title
Gluteus medius muscle fatigue
Description
Surface Electromyographic analysis performed for testing gluteus medius activity
Time Frame
from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Title
Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)
Description
This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score. This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score.
Time Frame
from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Title
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
This measures health status as it relates to the hip. There are 3 subscales, pain which score ranges from 0-20, stiffness range from 0-8, physical function ranging from 0-68. The total score is just added up from the subscales.
Time Frame
from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Title
Change in Oxford scale
Description
The Oxford scale is a physiotherapist objective-rated scale to asses muscle strength against the resistance. It is graded from 0 (flicker of movement) to 5 (Through full range actively against strong resistance)
Time Frame
from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Title
Change in SF-36 scale
Description
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Time Frame
from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Title
Change in Visual Analog Scale (VAS) scale
Description
To measure pain. This is a line with left most end representing no pain with the rightmost representing extreme pain. The participant puts a line where they feel that day and it is measured with a ruler to determine score out of 100. The line is 100mm long.
Time Frame
from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Title
Change in biomechanical gait balance
Description
Done by a biomechanics lab for patients to test their gait balance
Time Frame
from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Title
Change in biomechanical coordination
Description
Done by a biomechanics lab for patients to test their hip movements coordination
Time Frame
from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Secondary Outcome Measure Information:
Title
Radiological analysis of implants positioning
Description
To measure angles associated with proper implants positioning
Time Frame
from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient's consent for anticipation in the study BMI less than 35 ability to walk the distance of 10m and stand up from the chair arthroplasty in one hip Exclusion Criteria: patient's lack of consent for anticipation in the study neurological diseases balance disorders reoperations in the area of endoprosthesis muscles diseases rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis) dizziness, vasovagal syncope
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Artur Stolarczyk, Ph. D
Organizational Affiliation
Orthopaedics and Rehabilitation Department, Medical University of Warsaw
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bartosz Maciąg
Organizational Affiliation
Orthopaedics and Rehabilitation Department, Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedics and Rehabilitation, Medical University of Warsaw
City
Warsaw
State/Province
Mazowieckie
Country
Poland
Facility Name
Orthopaedics and Rehabilitation Department, Medical University of Warsaw
City
Warsaw
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21978244
Citation
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Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach

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